Job Description:
Job Purpose: Responsible for developing new medical devices
Duties:
Act as technical lead in the development of new products, primarily class I and class II single-use medical devices
Lead Project Management activities such as budgets, resources, timelines, and deliverables
Provide primary interface to customer for communication of project status and plans
Develop and define product and customer requirements
Lead product and process risk assessments
Participate in design reviews
Write and execute protocols for design verification and validation
Lead test method development and have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
Oversee and perform testing and inspection of prototypes and pre-production products
Analyze test data, interpret results and formulate conclusions
Lead investigation of device failures to determine root cause and corrective action
Develop assembly methods and oversee prototype builds
Lead process development activities, write work instructions, and develop in process inspection procedures
Generate CAD models for test or assembly fixtures
Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
Investigate, evaluate and select product materials
Prepare detailed component and assembly drawings
Prepare documentation to support design history files and regulatory submissions
Maintain DHF and ensure documents are complete, accurate, and current
Communicate effectively with customers and vendors in a technical capacity
Skills/Qualifications:
BS in Engineering or equivalent technical degree
5 - 12 years relevant experience in product development, preferred
Proven ability to lead a product development program
Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software
Experience with plastics and/or silicones, particularly injection molding
Knowledge of medical device regulations (FDA/ISO)
Personal Attributes:
Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
Comfortable and productive in a fast-paced, entrepreneurial environment
A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients
Commitment to excellence and quality service to external and internal customer
Commitment to established policies and procedures, while contributing to continuous improvements
Excellent communication skills (oral and written)
Proficient (or better) computer skills, including Excel and Word
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